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Lcr35 / ICU / P. Aeruginosa

This study has been terminated.
(Recruiting or enrolling participants has halted and will not resume)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00621803
First Posted: February 22, 2008
Last Update Posted: February 22, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Université d'Auvergne
Information provided by:
University Hospital, Clermont-Ferrand
  Purpose
Preventing carriage of potentially pathogenic micro-organisms from the aerodigestive tract is an infection control strategy used to reduce the occurrence of nosocomial infections - including ventilator-assisted pneumonia - in intensive care units. The use of antibiotics is controversial and can lead to adverse effect such as the selection of highly resistant pathogens. The purpose of this study was to investigate the effect of oral administration of a probiotic strain, Lactobacillus, on gastric and respiratory tract colonisation/infection by Pseudomonas aeruginosa strains, according to the concept that an indigenous flora has a protective effect against secondary colonisation.

Condition Intervention
Pseudomonas Infections Drug: Probiotic Lactobacillus casei rhamnosus (Lcr35)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Prevention of Gastric Colonisation by Antibiotic Resistant Pseudomonas Aeruginosa Strains Using Oral Probiotic in ICU-Patients

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Delay in P.aeruginosa colonisation

Secondary Outcome Measures:
  • Delay of respiratory tract infection or colonisation due to P.aeruginosa. Persistance of L.casei rhamnosus in to the stomach

Enrollment: 400
Study Start Date: March 2003
Estimated Study Completion Date: October 2005
Estimated Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Detailed Description:
In this prospective double-blind randomised study, ICU patients receive twice a day either an oral dose of Lactobacillus casei rhamnosus, the available pharmaceutical form, or a placebo. Digestive tract carriage of Pseudomonas aeruginosa is monitored by cultures of gastric aspirates. The occurrence of respiratory tract colonisations / infections is monitored throughout the study. Evaluation criteria are the delay and the rates of gastric P. aeruginosa colonisation and respiratory tract infection or colonisation. Chi-square or two tailed Fisher exact test are used for comparing qualitative variables and Student's t-test or mann-Whitney test for quantitatives variables. The mean of non-acquisition expectancy (NAE), length of stay without P. aeruginosa acquisition, was calculated and P. aeruginosa non-colonized patient rates were estimated and the two groups compared with regard to survival curves from grouped data using the Kaplan Meier method and the Logrank test. Variables with a P. value ≤0.15 in the univariate analysis were included in a logistic regression and a Cox regression model for multivariate analysis.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • more than 18 years old
  • length of stay longer than 48h
  • with a nasogastric feeding tube

Exclusion Criteria:

  • - less than 18 years old
  • length of stay < 48h
  • immunosuppression
  • absolute neutrophile count < 500/mm3
  • gastro-intestinal bleeding
  • contraindicated enteral feeding
  • positive P. aeruginosa gastric aspirates or respiratory tract specimens during the first four days after hospital admission
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00621803


Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Université d'Auvergne
Investigators
Principal Investigator: Christophe De Champs, MD PhD University Hospital, Clermont-Ferrand
  More Information

Responsible Party: Christophe De Champs, Chu Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00621803     History of Changes
Other Study ID Numbers: CHU-0029
AFSSAPS 1220/CM/FE02
First Submitted: February 11, 2008
First Posted: February 22, 2008
Last Update Posted: February 22, 2008
Last Verified: February 2008

Keywords provided by University Hospital, Clermont-Ferrand:
Probiotic
Pseudomonas aeruginosa
Gastric colonization
Respiratory tract colonization
Ventilator aquired pneumoniae
determine the effect of oral administration of this probiotic on gastric and respiratory tract colonisation/infection by P. aeruginosa

Additional relevant MeSH terms:
Pseudomonas Infections
Gram-Negative Bacterial Infections
Bacterial Infections